This patent is directed to the development of therapy management systems and methods, and, in particular, to the development of therapy management systems and methods that involve modification of the structure and/or operation of a medical device or system used in conjunction with the therapy.
Therapy, or treatment, for a medical condition may be characterized in a number of different ways. For example, therapy may be discussed in terms of the agent used to affect a change in the patient's condition, such as a drug or radiation. As another example, therapy may be discussed in terms of the mode or route of administration.
Infusion therapy—the intravenous delivery (i.e., delivery into a vein) of therapy—is well known in the art. In its simplest form, infusion therapy may be carried out using a container or bag connected to a patient via a drip chamber, an administration set and a catheter. In such a system and according to such a method, fluid passes from the bag to the patient under the influence of gravity. In a more complex system, a pump or a cuff may be used to control the flow of the fluid to the patient.
Improvements to pumping systems used with infusion therapy have included the introduction of pump controllers. Certain pump controllers may be used as a central point for programming one or more pumps. The pump controller may also be used as a central point for displaying information concerning the operation of the pumps and related sensors. Further, the pump controller may be used as a central point for communication between the pumps and sensors and remote computerized systems, such as record-keeping systems for patient information and databases of pharmaceutical information.
Despite the inclusion of the pump controller, infusion therapy management has conventionally involved human intervention, in the form of one or more clinicians administering the process. For example, the clinician may examine the historical data from pump or the patient's chart regarding the therapy (flow rate, volume infused, etc.). The clinician may then combine this data with additional data regarding the patient's condition such as may be obtained from an instrument (e.g., blood pressure cuff, heart monitor, etc.), the patient's chart or the patient directly. Finally, the clinician will exercise his or her medical judgment regarding changes to the therapy.
The development of new therapy management techniques thus typically rely upon a clinician's expertise, and must face the challenge of a rigorous regulation scheme as well. Taking drug delivery as an example, developments tend to occur as to a particular drug and a particular route of delivery. Even in those instances where certain changes of therapy have been automated (e.g., where the pump automatically modifies its operation in accordance with a sensor reading), the development has been isolated to a particular drug and/or required continued intensive clinician involvement to manage the system. Certainly, the nature of the focus is influenced by the need to obtain regulatory approval prior to wide-spread release of the therapy, which approval is only obtained after extensive development and testing of such unique systems. One effect of the isolated nature of development is a proliferation of unique single-use or limited-use systems, methods and/or devices, with the attendant problems of supplying and supporting each of these devices.
As set forth in greater detail below, the present disclosure sets forth an improved assembly embodying advantageous alternatives to the conventional devices and methods discussed above.